What you should know:
– C2i Genomics, a cancer intelligence company, is launching its C2inform minimal residual disease (MRM) test across Europe, having obtained CE-IVD mark in the EU, UK and Switzerland. The company also announced the completion of several clinical trials around the world, including at leading cancer centers in Europe, the United States and Singapore.
– The new clinical data will be presented at the American Association for Cancer Research (AACR) 2022 Annual Meeting in New Orleans, Louisiana next week. C2inform is the first software MRD test as a CE marked medical device and will be available in countries accepting the CE mark. The test provides a streamlined process for in-house use by any pathology lab and genomic cancer lab so the test can be offered closer to the patient.
How it works
The C2inform test works by applying whole genome sequencing and artificial intelligence to just 3-4ml of blood sample to enable rapid and accurate cancer detection, monitoring of disease progression and assessment of therapeutic efficacy. The test enables informed and timely personalized treatment decisions and supports the development of more effective cancer treatments through pharmaceutical drug development partnerships. The test requires significantly reduced laboratory operation complexity, eliminates the need to develop a patient-specific test, and offers a rapid, high-throughput solution for cancer patients across the EU.
This European regulatory certification indicates C2inform’s compliance with high safety, health and environmental protection standards and allows commercial sale to cancer diagnostic laboratories that require CE marking. The CE mark is a prerequisite for reimbursement of diagnostic tests by health authorities and, in some European countries, it is required before laboratories can use a new test method. Early adopters include several leading cancer centers in Denmark, Switzerland, France and the UK, and an industry partnership with OncoDNA, a genomics and theranostics company that was announced as a strategic partner of C2i Genomics in beginning of 2022.